Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05898854
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-06-02
Brief Title:
68GaGa-FAPI PETCT in Gastric and Gastroesophageal Junctional Cancer
Sponsor:
Aalborg University Hospital
Organization:
Aalborg University Hospital
Study Overview
Official Title:
68GaGa-FAPI PETCT The Dagnostic Accuracy for Primary Staging and Re-staging After Chemotherapy in Patients With Gastric and Gastro-esophageal Junctional Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Twenty n20 patients with gastric cancer or gastro-esophageal junctional cancer will undergo FAPI PETCTs in addition to routing diagnostic workup including FDG PETCT at primary staging and restaging
The FAPI PETCT results will be compared to conventional imaging including FDG PETCT using histopathology as reference standard and the diagnostic accuracy will be determined FAP-immunohistochemistry will be conducted in surgical specimens FAPI PETCTs impact on patient management and the prognostic value of FAPI PETCT will be evaluated
The FAPI PETCT results will be compared to conventional imaging including FDG PETCT using histopathology as reference standard and the diagnostic accuracy will be determined FAP-immunohistochemistry will be conducted in surgical specimens FAPI PETCTs impact on patient management and the prognostic value of FAPI PETCT will be evaluated
Detailed Description:
A new and promising PET-tracer in oncology has been developed Gallium-68 labelled fibroblast activation protein inhibitor FAPI In general FAPI PETCT delivers increased sensitivity compared to 18F-Fluorodeoxyglucose FDG PETCT in cancer types of mesenchymal origin ie sarcomas and in cancers characterized by a large proportion of stromal cells such as gastric and pancreatic cancers It is currently debated whether FAPI PETCT will take over FDG PETCTs well-established role in oncological PETCT but more studies are needed to evaluate the diagnostic accuracy The clinical interest in FAPI extends beyond the use as a diagnostic tool as the 68Ga-isotope can be replaced by a β-emitting isotope eg 177-Lu or 90-Y enabling radionuclide therapy of FAPI-avid cancers
In recent comparative studies of FDG- and FAPI PETCT all primary tumors of the stomach were detected on FAPI PET whereas the reported detection rate on FDG PET ranged from 40 to 86 Regarding metastases FAPI PETCT showed comparable or better detection rate for regional lymph nodes but outperformed FDG PETCT in the detection of peritoneal and other distant metastases Re-staging with FAPI PET after chemotherapy has been attempted in only a handful of patients and seems feasible
Even though the results of FAPI PETCT compared to conventional imaging seem convincing there are several limitations and therefore FAPI PETCT is not yet implemented in cancer diagnostics
The investigators are conducting a prospective explorative study complying with the Standard for Reporting Diagnostic Accuracy STARD criteria where 20 patients with gastric cancer or gastro-eophageal junctional cancer are recruited
Study subject will undergo FAPI PETCT at primary staging before treatment ie neoadjuvant chemotherapy or surgery and at restaging after neoadjuvant chemotherapy - before surgery in addition to routing diagnostic workup including FDG PETCT The FAPI PETCT will be blinded and the choice of treatment will not be influence by the FAPI PETCT results The additional scans will not interfere with or delay routine diagnostic workup or treatment
The FAPI PETCTs at primary staging and restaging will be compared to the corresponding FDG PETCTs and histopathology of biopsied material and surgical specimens will serve as reference standard FAPI PETCTs before and after neoadjuvant chemotherapy will be assessed and compared to the FDG PETCTs FAP-immunohistochemistry will be conducted in surgical specimens A tentative retrospective Multi-Disciplinary Team conference MDT will be arranged where treating clinicans are presented the FAPI PETCT and potential changes in patient management will be evaluated This tentative MDT will not influence patient management Follow up will be conducted for 10 years to evaluate the prognostic value of FAPI PETCT
In recent comparative studies of FDG- and FAPI PETCT all primary tumors of the stomach were detected on FAPI PET whereas the reported detection rate on FDG PET ranged from 40 to 86 Regarding metastases FAPI PETCT showed comparable or better detection rate for regional lymph nodes but outperformed FDG PETCT in the detection of peritoneal and other distant metastases Re-staging with FAPI PET after chemotherapy has been attempted in only a handful of patients and seems feasible
Even though the results of FAPI PETCT compared to conventional imaging seem convincing there are several limitations and therefore FAPI PETCT is not yet implemented in cancer diagnostics
The investigators are conducting a prospective explorative study complying with the Standard for Reporting Diagnostic Accuracy STARD criteria where 20 patients with gastric cancer or gastro-eophageal junctional cancer are recruited
Study subject will undergo FAPI PETCT at primary staging before treatment ie neoadjuvant chemotherapy or surgery and at restaging after neoadjuvant chemotherapy - before surgery in addition to routing diagnostic workup including FDG PETCT The FAPI PETCT will be blinded and the choice of treatment will not be influence by the FAPI PETCT results The additional scans will not interfere with or delay routine diagnostic workup or treatment
The FAPI PETCTs at primary staging and restaging will be compared to the corresponding FDG PETCTs and histopathology of biopsied material and surgical specimens will serve as reference standard FAPI PETCTs before and after neoadjuvant chemotherapy will be assessed and compared to the FDG PETCTs FAP-immunohistochemistry will be conducted in surgical specimens A tentative retrospective Multi-Disciplinary Team conference MDT will be arranged where treating clinicans are presented the FAPI PETCT and potential changes in patient management will be evaluated This tentative MDT will not influence patient management Follow up will be conducted for 10 years to evaluate the prognostic value of FAPI PETCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505916-40-00 | OTHER | European Union Clinical Trial number EU CT number | None |